Use of Mysimba in Patients With Weight Regain After Bariatric Surgery

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Although bariatric surgery is currently the most effective treatment for morbid obesity, weight regain occurs in 16-37% of the patients (1). Weight regain is not regularly treated with antiobesity medications (AOMs).

Mysimba (Contrave in US) is a AOM, it is a combination of naltrexone hydrochloride extended release and bupropion hydrochloride extended release for the treatment of obesity, and is used with lifestyle modification. Bupropion is a mild reuptake inhibitor of dopamine and norepinephrine. Naltrexone, an opioid antagonist has minimum effect on weight loss on its own. Naltrexone is thought to block the inhibitory effects of opioid receptors activated by the β-endorphin released in the hypothalamus that stimulates feeding, thus allowing the inhibitory effects of α-melanocyte stimulating hormone to reduce food intake. In patients with obesity usage of Naltrexone/Bupropion (NB) results in up to 8.2% weight loss (2). There is some evidence that also in bariatric patients with weight regain NB leads to additional weight loss (3, 4).

At the Nederlandse Obesitas Kliniek (NOK) weight regain at follow-up is currently treated with the Back on Track (BOT) program. The BOT program is an extra intervention our clinic provides for the patients who have weight regain after surgery, this is part of our standard care program.

The primary objective is to study the effect of naltrexone/bupropion in combination with the BOT module on successful weight loss(>5% weight loss) after 22 weeks in patients with weight regain after bariatric surgery, compared to the regular BOT module.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zuyderland Medisch Centrum
• Collaborator: Nederlandse Obesitas Kliniek
• Treatments: Bupropion; Naltrexone

Criteria

Inclusion Criteria:

• BMI before surgery was ≥ 35,0 kg/m2

• Patient has undergone a primary banded/non-banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)

• Gaining more than 5% weight after reaching plateau phase of lowest weight

Exclusion Criteria:

• Anatomical or surgical abnormalities for which revisional surgery is indicated.

• Use of the following medication Monoamino-oxidase inbibitors (MAO), selective serotonin reuptake inhibitor (SSRI), Tricyclic antidepressants (TCA), haloperidol, risperidone, opioids, antiarrhythmics, betablockers, antiviral medication (HIV)

• Pregnancy or breastfeeding

• Patients suffering from:

• unregulated hypertension

• a tumour in the central nervous system

• severe liver failure

• end stage kidney failure

• Patients suffering from or with a history of insults

• Patients with a history of:

• bipolar disease

• bulimia or anorexia nervosa

• Patients withdrawing from alcohol or benzodiazepines

• Patients who are not able to understand the informed consent form and patient information.